Accriva Diagnostics, Inc.

4 FDA enforcement actions

4 Total Recalls

0 Class I

3 Class II

1 Class III

Firm Details

Product Types: device
States: CA

All Recalls

Class II: Risk 11/05/2025 device

Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
Class III: Low Risk 10/21/2025 device

Due to an device without a premarket clearance being incorrectly package and distributed.
Class II: Risk 12/02/2024 device

Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.
Class II: Risk 09/27/2024 device

Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.